Making science work

Description

One central goal in developing medicinal products is to have for the drug just the right dose for the right time at site of action to assure optimal therapy for the patient. To achieve this central goal an understanding of drug delivery and its relation to the formulation is key.

PK/PD correlation links pharmacokinetics and pharmacodynamics to establish and evaluate dose-concentration-response relationships and subsequently describe and predict the effect-time courses resulting from a drug dose. On the other hand, the drug release profile from the formulation forms the input to the pharmacokinetic profile.

Thus, a well-characterized PK/PD model is an important tool in guiding the design of future experiments and trials for the preclinical, clinical and of course formulation development of drugs. It can be used with preclinical data to mathematically describe the dynamic in vivo behavior of new drug candidates, and to predict human exposure and effect based on preclinical models as well as directing demands in drug release profiles. In the clinical phase of product development it can also be used to further optimize dosing and formulations for target patient groups.

During this seminar you will learn how PK/PD can be used together with in vitro and in vivo models to help you during formulation development to explore the advantage of tailor-made drug delivery solutions and to better evaluate drug release and efficacy.

Target groups

This seminar is addressing Pre-formulation scientists, Formulation development scientists, DMPK Scientists (Biopharmaceutics), Related disciplines (auch as regulatory affairs, project management…), Modelling and Simulation scientists (DMPK and Formulation related) as well als all members from Health Authorities.

Please Notice: Limited places for full time students available; written evidence must be submitted.

Objective

Goals

• Bring together Biopharmaceutics and formulation development experts
• Inform about current use of modelling and simulation and how it impacts the work of formulation development experts and overall project timing
• Understand key success parameters by case studies
• Discuss “setting clinical relevant specifications”